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EUGIA-ONDANSETRON is a brand name for Ondansetron, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults (18-64 years of age) Ondansetron Injection BP/Eugia-Ondansetron Injection (ondansetron hydrochloride dihydrate;) is indicated for: • the prevention of nausea and vomiting associated with emetogenic chemotherapy, including high dose cisplatin. • the prevention and treatment of post-operative nausea and vomiting.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Visually inspect IV solutions and discard if particulate matter or discolouration are observed. 4 Administration. Ondansetron Injection BP/Eugia-Ondansetron Injection clearance is reduced in patients with moderate or severe hepatic impairment.
Their total daily dose should not exceed 8 mg, which may be given as a single intravenous or oral dose. See 7 WARNINGS AND PRECAUTIONS, Hepatic. Ondansetron Injection BP/Eugia-Ondansetron Injection has important cardiac side-effects (dose-dependent QTc prolongation, coronary artery spasm, myocardial ischemia, and sequelae).
These effects are reported more often with intravenous administration, and are expected to be greater with a faster rate of infusion. 2 Pharmacodynamics, Electrocardiography. Though ondansetron hydrochloride dihydrate efficacy and tolerance were similar for elderly compared to younger adults in chemotherapy clinical trials, exposure-response modelling predicted a greater effect on QTcF in patients ≥75 years of age compared to young adults.
3 Pharmacokinetics, Geriatrics. Dosing considerations that reduce cardiac risks: o Use the minimum effective dose. o Consider use of an oral ondansetron formulation (lower Cmax).
Note:
Ondansetron Injection BP/Eugia-Ondansetron Injection is only available as a solution for injection. o Infuse slowly, over a minimum of 15 minutes. o Maximum IV dose is 16 mg (adults). o Consider ECG monitoring if treating elderly patients with an IV dose of 16 mg.
There is an increased risk for slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min. 4 Administration): Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 6 of 46 − Elderly (age ≥65 years): all IV doses − Adults (age <65 years): IV doses >8 mg.
g. at 4 and 8 hours). Cardiac side effects have been reported after subsequent dosing. The efficacy of ondansetron hydrochloride in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy.
1 Dosing Considerations. • Adults - Initial IV dose of 8 mg (max 16 mg) infused over 15 minutes, given at least 30 minutes before chemotherapy or - Initial IV dose of 8 mg (max 16 mg) infused over 15 minutes, given at least 30 minutes prior to chemotherapy, followed by two additional IV doses of 8 mg given at 4 and 8 hours after the initial dose For the maintenance of anti-emesis beyond the first 24 hours, patients should be switched to an oral formulation.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Ondansetron hydrochloride dihydrate has been administered to over 2500 patients worldwide in controlled clinical trials and has been well tolerated.
Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 14 of 46 The most frequent adverse events reported in controlled clinical trials were headache (11%) and constipation (4%). Other adverse events include sensations of flushing or warmth (< 1%).
Cardiovascular:
There have been rare reports of tachycardia, angina (chest pain), bradycardia, hypotension, syncope and electrocardiographic alterations.
Central Nervous System:
There have been rare reports of seizures. 3%.
Dermatological:
Rash has occurred in approximately 1% of patients receiving ondansetron. g. blurred vision) have been reported during or shortly after intravenous administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 minutes.
Hepatic/ Biliary / Pancreatic There were transient increases of SGOT and SGPT of over twice the upper limit of normal in approximately 5% of patients. These increases did not appear to be related to dose or duration of therapy. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.
, Hepatic. Ondansetron Injection BP/Eugia-Ondansetron Injection has important cardiac side-effects (dose-dependent QTc prolongation, coronary artery spasm, myocardial ischemia, and sequelae). These effects are reported more often with intravenous administration, and are expected to be greater with a faster rate of infusion.
2 Pharmacodynamics, Electrocardiography. Though ondansetron hydrochloride dihydrate efficacy and tolerance were similar for elderly compared to younger adults in chemotherapy clinical trials, exposure-response modelling predicted a greater effect on QTcF in patients ≥75 years of age compared to young adults.
3 Pharmacokinetics, Geriatrics. Dosing considerations that reduce cardiac risks: o Use the minimum effective dose. o Consider use of an oral ondansetron formulation (lower Cmax).
Note:
Ondansetron Injection BP/Eugia-Ondansetron Injection is only available as a solution for injection. o Infuse slowly, over a minimum of 15 minutes. o Maximum IV dose is 16 mg (adults). o Consider ECG monitoring if treating elderly patients with an IV dose of 16 mg.
There is an increased risk for slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min. 4 Administration): Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 6 of 46 − Elderly (age ≥65 years): all IV doses − Adults (age <65 years): IV doses >8 mg.
g. at 4 and 8 hours). Cardiac side effects have been reported after subsequent dosing. The efficacy of ondansetron hydrochloride in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy.
1 Dosing Considerations. • Adults - Initial IV dose of 8 mg (max 16 mg) infused over 15 minutes, given at least 30 minutes before chemotherapy or - Initial IV dose of 8 mg (max 16 mg) infused over 15 minutes, given at least 30 minutes prior to chemotherapy, followed by two additional IV doses of 8 mg given at 4 and 8 hours after the initial dose For the maintenance of anti-emesis beyond the first 24 hours, patients should be switched to an oral formulation.
• Ondansetron Injection BP/Eugia-Ondansetron Injection is contraindicated in patients with a history of hypersensitivity to the drug or any components of its formulations. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ondansetron in Canada.
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Note:
Ondansetron Injection BP/Eugia-Ondansetron Injection is only available as a solution for injection. • Pediatrics (<18 years of age) Ondansetron Injection BP/Eugia-Ondansetron Injection is not approved this use in children. 1 Dosing Considerations.
• Adults: o initial IV dose of 8 mg, infused over 15 minutes, given 30 minutes before chemotherapy For maintenance of anti-emesis, patients should be switched from Ondansetron Injection USP to an oral formulation.
Note:
Ondansetron Injection BP/Eugia- Ondansetron is only available as a solution for injection. Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 7 of 46 • Pediatrics (4-<18 years of age) o initial IV dose 3 to 5 mg/m2, infused over 15 minutes, at least 30 minutes before chemotherapy.
For maintenance of anti-emesis, patients should be switched from Ondansetron Injection USP to an oral formulation.
Note:
Ondansetron Injection USP is only available as a solution for injection. • Pediatrics (< 4 years of age) Ondansetron Injection USP is not indicated for use in children under 4 years of age. 4 Administration), infused over 15 minutes, given at least 30 minutes prior to chemotherapy.
o may be followed by two IV doses of 8 mg, diluted, infused over 15 minutes, at least 4 hours apart. * When the initial dose is 16 mg, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
ECG monitoring may be considered. • Geriatrics (≥75 years of age) o initial IV dose should be 8 mg maximum, diluted, infused over 15 minutes, given at least 30 minutes prior to chemotherapy. 4 Administration), infused over 15 minutes, at least 4 hours apart.
** For the third dose, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min. ECG monitoring may be considered. Prevention and Treatment of Post-Operative Nausea and Vomiting • Adults: o Prevention: 4 mg IV, undiluted, infused – preferably over 2-5 minutes, and not less than 30 seconds, at induction of anaesthesia.
o Treatment: a single dose of 4 mg IV, infused – preferably over 2-5 minutes, and not less than 30 seconds. • Pediatrics (< 18 years of age) Health Canada has not authorized an indication for the prevention or treatment of post- operative nausea and vomiting in children.
• Geriatrics Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 8 of 46 Health Canada has not authorized an indication for the prevention or treatment of post- […]
The etiology of the liver failure is unclear.
Hypersensitivity:
Rare cases of immediate hypersensitivity reactions sometimes severe, including anaphylaxis, bronchospasm, urticaria and angioedema have been reported.
Local Reactions:
Pain, redness and burning at the site of injection have been reported.
Metabolic:
There have been rare reports of hypokalaemia. 5 Post-Market Adverse Reactions Over 250 million patient treatment days of ondansetron hydrochloride dihydrate have been supplied since the launch of the product worldwide. The following events have been spontaneously reported during post approval use of ondansetron hydrochloride dihydrate, although the link to ondansetron cannot always be clearly established.
Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 15 of 46 The adverse event profiles in children and adolescents were comparable to that seen in adults. , laryngeal oedema, stridor, laryngospasm and cardiopulmonary arrest) have also been reported.
01%) of myocardial infarction, myocardial ischemia, angina, chest pain with or without ST segment depression, arrhythmias (including ventricular or supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), electrocardiographic alterations (including second degree heart block), palpitations and syncope.
Rarely and predominantly with intravenous ondansetron, transient ECG changes including QTc interval prolongation, Torsade de Pointes, ventricular fibrillation, coronary artery spasm, myocardial ischemia, cardiac arrest, and sudden death have been reported.
(see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Eye Disorder:
There have been very rare cases of transient blindness following ondansetron treatment, generally within the recommended dosing range and predominantly during intravenous administration. The majority of blindness cases reported resolved within 20 minutes.
Although most patients had received chemotherapeutic agents, including cisplatin a few cases of transient blindness occurred following ondansetron administration for the treatment of post-operative nausea or vomiting and in the absence of cisplatin treatment.
Some cases of transient blindness were reported as cortical in origin. Hepatic/ Biliary / Pancreatic Occasional asymptomatic increases in liver function tests have been reported. 1%) have been reported predominantly during or upon completion of IV infusion of ondansetron.
), movement disorders and dyskinesia have been reported without definitive evidence of persistent clinical sequelae. Serotonin syndrome and neuroleptic malignant syndrome-like events have been reported with 5-HT3 receptor antagonist antiemetics, including ondansetron hydrochloride dihydrate, when given in combination with other serotonergic and/or neuroleptic drugs (see 7 WARNINGS AND Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 16 of 46 PRECAUTIONS, Neurologic).
Respiratory, Thoracic and Mediastinal Disorders:
There have also been rare reports of hiccups.
Skin and Subcutaneous Tissue Disorders:
Very rare reports have been received for bullous skin and mucosal reactions, including fatal cases. These reports include toxic skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and have occurred in patients taking other medications that can be associated with bullous skin and mucosal reactions.
Note:
Ondansetron Injection BP/Eugia-Ondansetron Injection is only available as a solution for injection. • Pediatrics (<18 years of age) Ondansetron Injection BP/Eugia-Ondansetron Injection is not approved this use in children. 1 Dosing Considerations.
• Adults: o initial IV dose of 8 mg, infused over 15 minutes, given 30 minutes before chemotherapy For maintenance of anti-emesis, patients should be switched from Ondansetron Injection USP to an oral formulation.
Note:
Ondansetron Injection BP/Eugia- Ondansetron is only available as a solution for injection. Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 7 of 46 • Pediatrics (4-<18 years of age) o initial IV dose 3 to 5 mg/m2, infused over 15 minutes, at least 30 minutes before chemotherapy.
For maintenance of anti-emesis, patients should be switched from Ondansetron Injection USP to an oral formulation.
Note:
Ondansetron Injection USP is only available as a solution for injection. • Pediatrics (< 4 years of age) Ondansetron Injection USP is not indicated for use in children under 4 years of age. 4 Administration), infused over 15 minutes, given at least 30 minutes prior to chemotherapy.
o may be followed by two IV doses of 8 mg, diluted, infused over 15 minutes, at least 4 hours apart. * When the initial dose is 16 mg, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min.
ECG monitoring may be considered. • Geriatrics (≥75 years of age) o initial IV dose should be 8 mg maximum, diluted, infused over 15 minutes, given at least 30 minutes prior to chemotherapy. 4 Administration), infused over 15 minutes, at least 4 hours apart.
** For the third dose, there is a predicted increase of the risk for a slight QTcF interval prolongation above 10 ms (from baseline) for about 10 min. ECG monitoring may be considered. Prevention and Treatment of Post-Operative Nausea and Vomiting • Adults: o Prevention: 4 mg IV, undiluted, infused – preferably over 2-5 minutes, and not less than 30 seconds, at induction of anaesthesia.
o Treatment: a single dose of 4 mg IV, infused – preferably over 2-5 minutes, and not less than 30 seconds. • Pediatrics (< 18 years of age) Health Canada has not authorized an indication for the prevention or treatment of post- operative nausea and vomiting in children.
• Geriatrics Ondansetron Injection BP/Auro-Ondansetron Injection Product Monograph Page 8 of 46 Health Canada has not authorized an indication for the prevention or treatment of post- operative nausea and vomiting in geriatric patients.
4 Administration Administration of Intravenous Infusion Solutions As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, […]
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